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. 2021 Jun 11;6(1):31-37.
doi: 10.22603/ssrr.2021-0035. eCollection 2022.

Efficacy and Safety of Condoliase Disc Administration as a New Treatment for Lumbar Disc Herniation

Masahiro Inoue  1 , Takeshi Sainoh  2 , Atsushi Kojima  3 , Masatsune Yamagata  4 , Tatsuo Morinaga  5 , Chikato Mannoji  6 , Hiromi Ataka  7 , Masaomi Yamashita  8 , Hiroshi Takahashi  9 , Junya Saito  10 , Takayuki Fujiyoshi  11 , Tetsuhiro Ishikawa  12 , Yawara Eguchi  13 , Kei Kato  14 , Sumihisa Orita  13 , Kazuhide Inage  13 , Yasuhiro Shiga  13 , Masaki Norimoto  10 , Tomotaka Umimura  12 , Yuki Shiko  15 , Yohei Kawasaki  15 , Yasuchika Aoki  1 , Seiji Ohtori  13
Affiliations

Efficacy and Safety of Condoliase Disc Administration as a New Treatment for Lumbar Disc Herniation

Masahiro Inoue et al. Spine Surg Relat Res. .

Abstract

Introduction: Condoliase is a newly approved drug that improves symptoms associated with lumbar disk herniation (LDH) by intradiscal administration. This study aimed to evaluate the mid-term outcomes of condoliase injection, examine the adverse events, including cases that required surgery after condoliase administration, and verify cases in which condoliase could be effective.

Methods: We enrolled patients with LDH who were treated conservatively for at least six weeks and received condoliase. We assessed the visual analog scale (VAS) score, Japanese Orthopaedic Association Back Pain Evaluation Questionnaire, Oswestry Disability Index, disk height, and disk degeneration for up to 6 months, and we examined the complications. Furthermore, a 50% or more improvement in leg pain VAS score was considered effective. Factors related to symptom improvement were investigated by determining whether lower limb pain improved in six months.

Results: In total, 84 patients were recruited (52 men, 32 women; mean age, 44.2 ± 17.1 [16-86 years]). The duration of illness was 6.7 ± 6.8 (1.5-30) months. All patient-based outcomes significantly improved at 4 weeks after the administration compared with pretreatment. The intervertebral disc height decreased significantly at four weeks after condoliase administration compared with that before administration. Progression of intervertebral disc degeneration occurred in 50% of the patients. Eleven patients underwent herniotomy due to poor treatment effects. Moreover, treatment in 77.4% of the patients was considered effective. A logistic regression analysis revealed that L5/S1 disk administration (p = 0.029; odds ratio, 5.94; 95% confidence interval, 1.20-29.45) were significantly associated with clinical effectiveness.

Conclusions: Condoliase disk administration improved pain and quality of life over time. Condoliase disk administration was more effective in L5/S1 intervertebral administration.

Keywords: Condoliase; conservative therapy; disk administration; disk degeneration; lower limb pain; lumbar disk herniation.

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Conflict of interest statement

Conflicts of Interest: The authors declare that there are no relevant conflicts of interest.

Figures

Figure 1.
Figure 1.
The measurement method of DHI. The formula of DHI is DHI = intervertebral disc height/cranial adjacent vertebral body height, where DHI = (BC + EF)/(AB + DE) in the figure. DHI, disk height index
Figure 2.
Figure 2.
Changes in visual analog scale scores after intervertebral condoliase administration. Lower limb pain and numbness significantly improved compared with baseline in all periods. Moreover, all items significantly improved between 4 and 12 weeks after the administration.
Figure 3.
Figure 3.
Change in the DHI (%) after intervertebral condoliase administration. The DHI (%) significantly decreased 4 weeks after the administration compared with that before administration, and no difference was observed at 4, 12, and 24 weeks after administration. DHI, disk height index
Figure 4.
Figure 4.
T2-weighted magnetic resonance images before (A, C) and 24 weeks after L4/5 intradiscal condoliase administration (B, D). The disk herniation at L4/5 disappeared at 6 months (white arrow). However, the disk height decreased (red arrow), and disc degeneration progressed.
See this image and copyright information in PMC

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